By Vinita Goyal, MD, MPH
Clinician Researcher, Alamo Women’s Health Clinic of Albuquerque, Albuquerque, NM
SYNOPSIS: A prospective study of U.S. patients obtaining medication abortion through telehealth platforms demonstrated high effectiveness (97.7%; 95% confidence interval [CI], 97.2% to 98.1%) and safety (99.8%; 95% CI, 99.6% to 99.9%).
SOURCE: Upadhyay UD, Koenig LR, Meckstroth K, et al. Effectiveness and safety of telehealth medication abortion in the USA. Nat Med 2024;30:1191-1198.
In June 2022, the U.S. Supreme Court, in its decision in Dobbs v. Jackson Women’s Health Organization, removed the previous constitutionally protected right to abortion.1 As a result, 14 states have completely banned abortion, exacerbating already compromised access.2 Despite this ruling, abortion incidence has increased.3 In particular, the use of medication abortion, often accessed through telemedicine, has increased.3-5 People seeking medication abortion via telemedicine may consult with a provider via phone or video (synchronous) or via secure text messaging (asynchronous) to determine eligibility and receive medications from a clinic (site-to-site) or via mail (direct-to-patient).6
This was a prospective study following pregnant people who obtained medication abortion from three virtual clinics between April 2021 and January 2022 to assess method effectiveness and safety. These virtual clinics offered synchronous and asynchronous medication abortion with mail order pharmacy delivery. Telehealth medication abortion was provided to medically eligible patients, determined by reported medical history, who were up to 10 weeks’ gestation established by date of last menstrual period or ultrasonography.
Patients were referred for pre-abortion ulstrasound if they had risk factors for, or symptoms of, ectopic pregnancy or if they potentially were beyond the limit of the virtual clinic based on history. Each clinic had two scheduled follow-up interactions: first, to confirm medication administration (both mifepristone and misoprostol) and assess symptoms of complete abortion three to seven days after intake; and, second, to determine results of a home urine pregnancy test (at two weeks for a low-sensitivity test or four weeks for a high-sensitivity test).
A total of 6,034 patients met eligibility criteria and took medication abortion. Of these, 1,600 patients additionally completed a baseline survey on the date of intake assessing sociodemographic characteristics and medical history, a second survey three to seven days after intake, and a final survey at four weeks after intake, the latter two to assess additional medical care and adverse events.
Primary study outcomes were effectiveness, defined as the proportion of completed abortions after the initial dose of mifepristone and misoprostol without subsequent intervention, and safety, defined as the proportion of abortions that were not followed by a serious abortion-related event, including blood transfusion, abdominal surgery to treat ectopic pregnancy, overnight hospital admission, or death. Abortion completion was determined by urine pregnancy test, ultrasonography, serum human chorionic gonadotropin testing, or patient symptom checklist.
Of 6,034 patients, 50.3% were 30 years of age or older, 62.7% with known race/ethnicity were white, 84.3% were less than seven weeks’ gestation, and 91.9% had no pre-abortion ultrasound. The majority (72.3%) received asynchronous care. Abortion outcomes were ascertained for 73.8%. Overall, 97.7% (95% confidence interval [CI], 97.2% to 98.1%) had a complete abortion without known intervention or ongoing pregnancy after the initial treatment (98.3% for the synchronous group vs. 97.4% for the asynchronous group, P = 0.06). Safety was similarly high at an overall estimate of 99.8% (95% CI, 99.6% to 99.9%) experiencing no serious adverse events (99.7% for the synchronous group vs. 99.6% for the asynchronous group, P = 0.67).
Among the 1,600 subjects who provided supplementary outcome data via the three additional surveys described earlier, effectiveness was reported as 96.7% and safety as 99.4%. Importantly, only six of 6,034 (0.16%) patients were diagnosed with ectopic pregnancy and 15 of 6,034 (0.25%) patients experienced a serious adverse event, including blood transfusion (0.10%), abdominal surgery to treat a ruptured ectopic pregnancy (0.02%), or overnight hospital admission (0.17%).
None of the patients included in this study were determined to be greater than 10 weeks’ gestation at subsequent follow-up, although the actual number of patients who had ultrasounds was not reported.
COMMENTARY
Use of medication abortion in the United States is increasing, and distribution through telehealth providers has sharply increased since constitutionally protected access to abortion was overturned.5,7 Medication abortion in the United States has a longstanding and well-documented history of safety and effectiveness through both in-person and telemedicine provision.8 This prospective study further corroborates the safety and effectiveness of telehealth medication abortion and particularly that of asynchronous provision.9
Despite the extremely safe and effective use of medication abortion, ongoing legal challenges threaten its availability. In March 2024, the U.S. Supreme Court heard arguments challenging Food and Drug Administration (FDA) approval of mifepristone and is expected to release its decision in June 2024 on withdrawing FDA approval, reinstating restrictions contrary to scientific evidence, which may require in-person dispensing or maintaining approval and current use of mifepristone. The American College of Obstetricians and Gynecologists leads an amicus brief outlining the overwhelming safety and effectiveness of mifepristone representing “two decades of scientific evidence based on hundreds of medical studies and millions of uses of mifepristone for medication abortion.”10
Claims against safety and effectiveness of medication abortion are unfounded. This study adds to the already substantial literature base detailing the safety and effectiveness of medication abortion. It also goes a step further, providing additional evidence in support of FDA labeling forgoing the in-person distribution requirement of mifepristone and misoprostol.11
Telehealth medication abortion is safe and effective, as compared to in-person administration, and it is an important tool in maintaining abortion access in the current era of state-based restrictions on abortion access. Providers who prescribe medication abortion via telehealth, as well as those practicing in states with abortion bans who provide follow-up care for patients who have used medication abortion obtained via asynchronous telehealth, should be confident that they are providing safe and effective evidenced-based care that is instrumental in maintaining abortion access.
REFERENCES
- SCOTUSblog. Dobbs v. Jackson Women’s Health Organization. https://www.scotusblog.com/case-files/cases/dobbs-v-jackson-womens-health-organization/
- Forouzan K, Guarnieri I. State policy trends 2023: In the first full year since Roe fell, a tumultuous year for abortion and other reproductive health care. Guttmacher Institute. Published Dec. 19, 2023. https://www.guttmacher.org/2023/12/state-policy-trends-2023-first-full-year-roe-fell-tumultuous-year-abortion-and-other
- Maddow-Zimet I, Gibson C. Despite bans, number of abortions in the United States increased in 2023. Guttmacher Institute. Published March 19, 2024. https://www.guttmacher.org/2024/03/despite-bans-number-abortions-united-states-increased-2023
- Aiken ARA, Wells ES, Gomperts R, Scott JG. Provision of medications for self-managed abortion before and after the Dobbs v Jackson Women’s Health Organization decision. JAMA 2024; Mar 25:e244266. doi:10.1001/jama.2024.4266. [Online ahead of print].
- Society of Family Planning. #WeCount Public Report, April 2022 to September 2023. Published Feb. 28, 2024. https://societyfp.org/wp-content/uploads/2024/02/SFPWeCountPublicReport_2.28.24.pdf
- Lerma K, Coplon L, Goyal V. Travel for abortion care: Implications for clinical practice. Curr Opin Obstet Gynecol 2023;35:476-483.
- Jones RK, Friedrich-Karnik A. Medication abortion accounted for 63% of all US abortions in 2023 — an increase from 53% in 2020. Guttmacher Institute. Published March 19, 2024. https://www.guttmacher.org/2024/03/medication-abortion-accounted-63-all-us-abortions-2023-increase-53-2020
- [No authors listed]. Medication abortion up to 70 days of gestation: ACOG Practice Bulletin summary, number 225. Obstet Gynecol 2020;136:855-858.
- Upadhyay UD, Koenig LR, Meckstroth K, et al. Effectiveness and safety of telehealth medication abortion in the USA. Nat Med 2024;30:1191-1198.
- American College of Obstetricians and Gynecologists. ACOG leads amicus brief calling mifepristone conclusively safe and effective. Published Feb. 10, 2023. https://www.acog.org/news/news-releases/2023/02/acog-leads-amicus-brief-calling-mifepristone-conclusively-safe-and-effective
- American College of Obstetricians and Gynecologists. Updated mifepristone REMS requirements. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/01/updated-mifepristone-rems-requirements
A prospective study of U.S. patients obtaining medication abortion through telehealth platforms demonstrated high effectiveness (97.7%; 95% confidence interval [CI], 97.2% to 98.1%) and safety (99.8%; 95% CI, 99.6% to 99.9%).
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